Description

Nalmefene Impurity 10 is a high-purity chemical reference standard used in the analytical profiling and quality control of pharmaceutical active ingredients. This compound is critical for ensuring the safety and efficacy of pharmaceutical products by serving as a well-characterized impurity marker. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical testing laboratories involved in drug development and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Nalmefene HCl drug substance and finished dosage forms.
• Method Development and Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, in compliance with ICH guidelines.
• Quality Control (QC) Testing: Employed in routine batch release testing to monitor impurity levels and ensure product specifications are met.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) during drug stability programs.
• Regulatory Submissions: Provides necessary impurity data for regulatory filings (e.g., FDA, EMA) to support drug approval applications (NDA, ANDA).
• Research and Development: Supports impurity characterization and route scouting during the synthetic process development of Nalmefene.

Basic Information

Product Name	Nalmefene Impurity 10
CAS No.	144265-45-2
Molecular Formula	C21H25NO3
Molecular Weight	339.43 g/mol
Synonyms	17-(Cyclopropylmethyl)-4,5α-epoxy-6-methylenemorphinan-3,14-diol; 6-Methylenenaltrexone; Nalmefene Related Compound; Nalmefene EP Impurity; Nalmefene USP Impurity; Opioid antagonist impurity; Morphinan derivative impurity
EINECS	Contact for details

Quality Control

Every batch of Nalmefene Impurity 10 is manufactured and tested under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including ICH Q3A/B guidelines for impurities. Comprehensive characterization is performed using advanced analytical techniques. Certificates of Analysis (COA) detailing purity, identity, and impurity profile are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled under dry conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.